The FDA's Dilemma About Ibuprofen And Cardiovascular Risk

“Long-term high-dose use of painkillers such as ibuprofen or diclofenac is ‘equally hazardous’ in terms of heart attack risk as use of the drug Vioxx, which was withdrawn due to its potential dangers, researchers said.”

The work being referenced appeared in the respected British medical journal, The Lancet. The painkillers discussed are known as non-steroidal anti-inflammatory drugs (NSAIDs) and are available around the world. The Lancet article discloses that for every 1,000 patients with an average risk of heart disease who take high-dose diclofenac or ibuprofen for a year, about three extra would have an avoidable heart attack, of which one would be fatal.

On balance, the risk-benefit ratio is not unreasonable, especially when one considers that all drugs have side-effects, even aspirin. However, for those who need pain medication to treat their arthritis, this has to be concerning. After all, arthritis patients tend to be older, overweight and limited in their exercise capacity due to their arthritic pain – all of which predispose these people to heart disease. Yet, the very medication that they need to ease their pain could prove dangerous.

The fact that NSAIDs pose cardiovascular (CV) risks is not new, and I wrote about this a few months ago. However, these latest data raise a new concern in that here is an over-the counter (OTC) drug, ibuprofen (brand names: Advil, Motrin), that has been found to pose the same CV risk as Vioxx (
Merck), a drug that was removed from the market. There is a natural tendency for people to view OTC medications as being far safer than prescription drugs. After all, you don’t need a doctor’s approval to obtain it. Furthermore, people don’t follow labels very well. If they are in pain, they may think: “Why take just two pills? Three or four may work better and faster. If these pills are dangerous, you would need a prescription to get them. They wouldn’t be available at a grocery store.” That a readily available OTC medication is as risky as a prescription drug that has been deemed unsafe for use is rare, if not unprecedented.

How, then, does the FDA respond to this situation? On the one hand, these drugs have been available for decades and have been taken by hundreds of millions of people around the world. For the vast majority of patients who need them, these drugs are totally safe. However, there is a subpopulation for whom they are not. For drugs available only by prescription, the FDA has the safety net made up of the prescribing physicians who can sit down with the patient and explain the risks of a specific drug. But for an OTC drug like ibuprofen, this is not an option. Patients at CV risk may be taking this NSAID and be unaware of its potential long-term adverse effect.

The FDA could take the step of pulling ibuprofen off the shelf and make it available only by prescription. My guess is that would be viewed by consumers as draconian and another example of unnecessary government intervention into private lives, akin to limiting the size of soda bottles in NYC. Yet, if the FDA does nothing, it essentially is accepting that three people out of every thousand at average risk of heart disease will have an avoidable heart attack. It will be interesting to watch how it deals with this dilemma.

I was the president of Pfizer Global Research and Development in 2007 where I managed more than 13,000 scientists and professionals in the United States, Europe, and Asia. I've received numerous awards including an Honorary Doctor of Science degree from the University of New...